Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The influence of tramadol on opioid-induced bowel dysfunction

This research is investigating the effects of tramadol, a type of pain medication, on a common side effect of other strong painkillers: bowel problems like constipation. Many people who take strong painkillers experience these issues, which can be very uncomfortable. The study aims to understand if tramadol can influence how food moves through the digestive system, specifically looking at how quickly it travels through the stomach and bowels. Participants will be given either tramadol or a dummy pill (placebo) to compare the effects. It's a Phase IV study, meaning tramadol is already approved, but researchers are gathering more information about its effects on this specific problem. The study is open to men aged 18 and older.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Aalborg University Hospital

Enrolment target

Start

31 May 2022

Opioid induced bowel dysfunction

What is this study about?

When people take certain strong painkillers for a long time, a common and often difficult side effect is problems with their bowels, such as constipation. This is known as opioid-induced bowel dysfunction. It can make life quite uncomfortable, as it affects how the digestive system normally works.

This study wants to find out if another painkiller called tramadol might have an effect on these bowel problems. Specifically, researchers are interested in seeing whether tramadol changes how quickly food and waste move through the stomach and gut. They'll be comparing tramadol to a 'dummy pill' (a placebo) to see if there's a real difference caused by the medication.

The main goal is to measure how long it takes for things to move all the way through the digestive system. They'll also look at whether tramadol helps with feelings of constipation, and other digestive symptoms. This type of study (Phase IV) means that tramadol is already used in medicine, but doctors are looking to understand more about its specific effects in this particular situation.

Key takeaways

This study explores how tramadol affects painkiller-related bowel problems.
It aims to measure how quickly food moves through the body.
Only men aged 18 and older can participate.
Participants will receive either tramadol or a dummy pill.
It uses various measures, including scans, to check gut movement and symptoms.

Who may be eligible?

This study is looking for volunteers to take part. To be considered, you need to be an adult, meaning you must be 18 years old or older.

It's important to know that this particular study is only open to men. Women cannot take part in this research.

There might be other health requirements or medications you're taking that could affect whether you can join, but these are the main points about age and sex.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you a man?
Are you currently experiencing bowel problems related to strong painkiller use?
Are you able to attend study appointments as required?

Answer every question to see your result.

What does participation involve?

If you join this study, you would likely have several visits to the clinic. During these visits, you would receive either the tramadol medication or a placebo (a tablet that looks the same but contains no active medicine). You wouldn't know which one you're getting. Researchers will measure how quickly food moves through your digestive system using special tests. You'll also be asked to answer questions about any constipation you experience and other digestive symptoms, possibly filling out questionnaires. Some assessments might involve scans like MRI to look at your stomach and bowels in more detail. The study will involve taking study medication as instructed and attending all scheduled appointments for measurements and check-ups. The total duration of your participation would depend on the study design.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be gaining a better understanding of your condition and potentially finding an option that helps manage your bowel issues. You might also contribute valuable information that could help others in the future. However, there are potential risks, such as experiencing side effects from the tramadol or the study procedures. It's also possible that the medication may not help improve your symptoms. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is opioid-induced bowel dysfunction?

It's when strong painkillers (opioids) cause problems with your digestion, usually making it harder for you to have a bowel movement (constipation).

What is tramadol?

Tramadol is a painkiller that doctors sometimes prescribe to help manage pain. This study is looking at how it affects the gut.

What does 'total gastrointestinal transit time' mean?

It's how long it takes for food and waste to travel all the way through your digestive system, from when you eat until you pass it.

What is a 'placebo tablet'?

A placebo is a 'dummy' tablet that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the actual medication.

Why is this study only for men?

Sometimes, studies focus on specific groups to get clear answers, and this particular study has chosen to include only men over 18 for their research.